JP4234585B2 - A kit comprising a medical fixator and a device for placing the fixator - Google Patents

Abstract

The kit ( 1 ) comprises a needle ( 3 ) for placing the fixing element ( 2 ), and the fixing element ( 2 ) comprises at least one stop part ( 5 ) and a threaded deformable part ( 7 ) joined to said stop part ( 5 ). According to the invention, the needle ( 3 ) and the fixing element ( 2 ) comprise means ( 3, 10; 30 ) for detachably connecting the stop part ( 5 ) to the proximal part ( 15 ) of the needle ( 3 ), said connection being solid enough to enable the stop part ( 5 ) to remain integral with the needle ( 3 ) during the manipulation of the kit ( 1 ) when said kit ( 1 ) is handled, also enabling it to be introduced into the body of a patient and enabling the needle ( 3 ) to be introduced into a wall ( 50 ), said connection, however, being able to be released when a traction force is exerted upon the needle ( 3 ), in the direction in which the needle is inserted, beyond a force threshold which is greater than the stress exerted upon the fixing element ( 2 ) as a result of said manipulation, whereby release of the fixing element enables the stop part ( 5 ) to be brought into a non-deformed position by means of elastic recall of said connection.

Description

  The present invention relates to a kit comprising a medical fixing device and a needle for arranging the fixing device. The invention also relates to a fixator which can be used with this needle.

  By using at least one fixator that is generally H-shaped, in particular two anatomical walls, such as the abdominal wall, in particular a prosthetic element or prosthesis element for a wall reinforcement, i.e. two It is known to fix by using at least one fixator comprising a locking bar and a flexible central rod connecting the locking bars. The fixator can be inserted through the wall. In this case, one of the two locking bars is locked to the prosthesis member, and the other locking bar is locked to the opposite wall of the prosthesis member. Moreover, a fixing device can also be made not to let a wall penetrate. In this case, the other locking bar is anchored inside the wall.

  Such a fixator can also be used to connect two walls in the body or to connect two anatomical sites in the body.

  US Pat. No. 5,203,864 (see FIG. 17), US Pat. No. 5,320,633 (see FIG. 1D), and US Pat. No. 4,696,300 (FIG. 2a). And in FIG. 2b) such a type of fixator and fixing technique is disclosed.

  There are several types of devices that can be used to place such a fixator.

  A first type of device comprises a hollow needle that can engage through one or more walls to be attached and has a tip opening. Both locking bars of the fixator can be folded so as to be parallel to the central rod, so that the fixator can be received in the cavity of the needle. The device further includes a proximal pusher. The pusher can slide within the needle, thereby pushing out one or more fixators housed within the needle. Thereby, the fixing device located at the most advanced position can be selectively released.

  The second type of device also includes a hollow needle. However, the needle has a slit on the side and receives only one of the locking bars of each fixture. The side slit can project the central rod of each fixing device and the other locking bar from the side surface of the needle.

  U.S. Pat. No. 4,935,028 discloses a surgical suturing system that can occlude wounds and incisions, particularly wounds and incisions in the cornea. The suturing system includes a support disk, a thread-like portion, and a needle. The support disk is connected to one end of the thread-like part, and the needle is connected to the other end of the thread-like part. After insertion into the cornea, the needle is separated or cut from the thread. Corresponding adjacent ends of the thread-like portion are curved to form anchors. Alternatively, the corresponding adjacent end of the thread-like portion receives the locking head.

  In this prior art system, there was a need to cut the needle from the thread and then anchor or lock the end of the thread, which was a practical limitation. This made the system unsuitable for use in incision minimization techniques such as laparoscopic surgery. Furthermore, although the application of tension by a fixing device is necessary to keep the two walls to be connected tightly to each other, in this system, such application of tension by the fixing device is realized. Is difficult. Such retention is essential in certain cases, such as complete tissue integration with the abdominal wall reinforcement, particularly in the treatment of the abdominal wall.

EP 1 090 590 discloses a needle with lateral slits and with a detachable fixator, the system according to this document is also as described above with a fixator Tension cannot be applied.
US Pat. No. 5,203,864 U.S. Pat. No. 5,320,633 U.S. Pat. No. 4,696,300 U.S. Pat. No. 4,935,028 European Patent Application Publication No. 1 090 590

  The present invention aims to overcome the disadvantages of the prior art.

  Accordingly, it is an object of the present invention to provide a kit in which the fixator can be placed while applying tension so that the two walls to be joined can be held tightly together.

  Another object of the present invention is to provide a kit that is specially constructed so that the abdominal wall reinforcement can be tightly pressed against the abdominal wall to be treated, whereby this reinforcement against the abdominal wall. It is to ensure good tissue integration.

  A further object of the present invention is to provide a kit that is fully adapted for use in minimal incision techniques such as laparoscopic surgery.

  Another object of the present invention is to provide such a kit that is particularly simple to construct and use, thereby extending the applicability.

  Another object of the present invention is to provide such a kit that can be disposable after a single use.

  The kit according to the present invention is a kit comprising a medical fixing device and a needle for arranging the fixing device, as is conventionally known, wherein the needle is one of the fixing targets of the fixing device. At least one locking member capable of penetrating a plurality of walls, or through a portion of the thickness of such a wall, wherein the fixator can engage the wall, and the locking A deformable thread-like member connected to the member, and the fixing device is elastically deformable in a connection region between the locking member and the deformable thread-like member. An elastically deformable position such that the locking member and the deformable threaded member can be substantially inscribed in the cross-section of the needle with respect to the thread member; and the locking member engages with the one or more walls. Non-deformation that secures anchor fixing of the fixator And it is movable over a period of a location.

  In the present invention, the needle and the fixing device include means for detachably connecting the locking member to the proximal end portion of the needle, and this connection is carried into the patient's body while holding the kit. Is strong enough to keep the locking member securely fixed to the needle during the operation of inserting the needle into the wall and pulling force against the needle in the needle insertion direction. When the stress on the fixing device exceeds a predetermined threshold value when it is applied, it is considered that the fixing member can be detached. It can be a deformation position.

  Therefore, the fixing device is released by pulling the needle in the insertion direction of the needle. This makes it possible to apply a certain tension by the fixator to the wall or walls to be attached. This tension application ensures that the two walls to be connected, such as the abdominal wall reinforcement and the abdominal wall to be treated, are held tightly together.

  The needle has a particularly simple structure and is small in size so that the kit according to the invention can be used very easily for both laparoscopic and direct access techniques.

  Anchoring can be obtained by accessing the wall in the wall area of the wall intended to receive the prosthesis member or by percutaneous access.

  The simplicity of the needle structure also means that the kit according to the invention can be configured to be disposable, in which case the needle can be configured to be disposable after a single use. Thus, a series of such kits can be housed in a single sterilization package. The package can be advantageously configured as a rack that allows the kits to be easily and continuously removed after opening. This package can in particular be of the blister type.

  The simplicity of this structure additionally means that the needle can be any suitable shape. In particular, the needle can have a curved tip or an arched tip, similar to the tip of a suture needle.

  This curved or arched shape makes it possible in particular to carry out a fixing operation using the H-shaped fixing device described above. In that case, the two locking bars of the fixator are arranged on the same surface of the tissue wall, in particular in the plane of the wall reinforcement. The deformable thread-like member engages in the thickness portion of the wall along the curved track corresponding to the track of the needle in the wall when the fixator is placed. Thus, the two locking bars are arranged in contact with an embedded prosthesis member such as a wall reinforcement. Thereby, reinforcement of a prosthesis member and effective anchoring can be performed.

  In one possible embodiment of the present invention, the needle includes an internal cavity that is open at the proximal end, and the needle receives a locking member of the fixator within the cavity.

  The detachable coupling means may comprise a wall portion of the needle that defines the cavity and a locking member of the fixing device, in which case the dimension of the cavity and the dimension of the locking member are related. The dimension is such that there is friction between the stop member and the needle wall.

  The detachable connecting means also protrudes toward the inside of the cavity in addition to or instead of the frictional connection, and the locking member must be exceeded when separating the fixing device. Can be provided with one or more bosses.

  Each boss can be formed by partial stamping, particularly in the proximal end of the needle.

In this case, in one embodiment of the present invention,
The needle comprises a proximal cavity such that it has a constant diameter over the proximal region intended to receive the fixator and gradually decreases in diameter in the distal region;
The fixture comprises a distal bar, a proximal bar and an intermediate member connecting the bars together, the distal bar having a flange, the diameter of which is the proximal region of the cavity Is slightly smaller than the diameter at which the flange can be introduced and slid into the proximal region of the cavity until the flange is wedged in the distal region of the cavity. And the length of the intermediate member is such that the proximal bar contacts the proximal end of the needle when the flange is positioned such that it can form a sufficient wedge within the cavity. , Have been with length.

  Therefore, the proximal end bar that comes into contact with the proximal end portion of the needle can regulate the insertion angle of the flange into the needle cavity to a predetermined value corresponding to a value at which an ideal wedge is obtained. . This ideal wedge stop is sufficient to resist the above-mentioned friction imposed on the fixator and when it is desired to release the connection between the needle and the fixator It does not pose a risk of damaging it.

  In another possible embodiment of the invention, the kit comprises a flexible thread-like part that is connected to the proximal end of the needle and the sleeve that receives the locking member of the fixator. Is done.

  In this case, the flexible thread-like portion increases the ease of movement of the needle with respect to the fixing device, thereby making the operation of the needle easier and penetrating the wall forming the attachment target. The needle can be inserted. In addition, a conventional suture needle can be used. In addition, the flexible thread-like portion ensures that the fixator is positioned away from the needle when the needle is operated. This can prevent the risk of premature separation of the fixator and needle during operation.

  In this case, a simple way to obtain a kit according to the invention is to prepare (or use) a tube made of a heat-shrinkable material, in particular polytetrafluoroethylene (PTFE), Heat shrinkage is carried out in the part of the tube intended to form a flexible thread-like part, and no heat shrinkage is carried out in the remaining part intended to form a sleeve.

  In this embodiment of the invention, the means for releasably connecting the sleeve dimension such that there may be friction between the fixator and the sleeve when the fixator is inserted into the sleeve. The dimensions of the fixator. Such dimensions can be determined in particular by appropriately selecting the diameter of a tube formed from a heat-shrinkable material.

  The means for removably connecting is further a lateral opening formed in the sleeve, in particular a part of the fixing device, such as one end of the locking member, which is removably engaged. It can have an opening. In this case, the detachment between the fixing device and the sleeve can be obtained by tearing the sleeve wall starting from the side opening (slot).

  The means for detachably connecting may further comprise a thread that is present in the sleeve and removably engages around the locking member of the fixator. In particular, the thread forms a loop around the locking member of the fixing device and can be torn. In the above case of using a tube formed from heat shrinkable material, the yarn is simply engaged into the tube prior to heat shrinking.

  In another possible embodiment of the invention, the needle and the locking member of the fixator are connected to each other via a material bridge, the material bridge being dimensioned such that it can be broken by a force exceeding a predetermined threshold. It is said. In this case, the needle and the fixing device can be molded as an integral member from the same material.

  The locking member of the fixator can be in the form of a bar connected to the deformable thread-like member in its substantially central region.

  The fixator can comprise a single locking member or can comprise two locking members connected to each other by a deformable thread-like member.

  These two locking members enable a reinforced effective anchoring as described above.

  The two locking members can in particular be in the form of bars. Since the locking member on the base end side is not introduced into the needle, the locking member on the proximal end side can be of any appropriate shape different from the bar shape, and the locking ability can be improved. For example, the locking member on the base end side can be formed into a ball shape, a disk shape, or a ring shape.

  Furthermore, according to the present invention, there is no restriction on the length of the deformable thread-like member. This deformable thread-like member can in particular be formed by a thread that can be used to form a suture. In this case, the locking member is used to form a knot. The deformable thread-like member can also be of a length that can allow multiple penetrations of the needle through one or more walls to be attached. In this second case, the deformable thread-like member has the ability to elastically return to a linear shape when inserted into a curved or wavy track in one or more walls to be attached. It can be relatively rigid so that it can be provided. This elastic return force ensures that the prosthesis member is pressed and held against the wall that received the fixture. Alternatively, the deformable thread-like member can have longitudinal elasticity for the same purpose.

  In addition, the fixator can be formed from a bioabsorbable material.

  In order to make the understanding of the present invention clearer, the present invention will be described in the following with reference to the accompanying drawings, in relation to the kit according to the present invention and with respect to the fixator provided in the kit according to the present invention. Some preferred embodiments are described by way of example only and not limitation.

  For simplification, when each member in the first embodiment is used again in other embodiments and modifications, the same reference numerals are used and the description thereof is omitted.

  1 and 2 show a kit (1) comprising a medical fixator (2) and a needle (3) for placing the fixator (2).

  The fixator (2) is molded as an integral member from an elastically deformable synthetic material that can be bioabsorbable. The fixing device (2) includes a first locking bar (5), a second locking bar (6), and a thread-like intermediate member (7) connecting the bars (5, 6). Yes.

  The fixator (2) is shown in its original form in FIG. That is, it is shown in a state where it has not undergone any deformation. In this configuration, the bars (5, 6) form an angle of approximately 90 ° between each other and the intermediate member (7) is 2 with respect to the angle formed by these bars (5, 6). It is oriented substantially perpendicular to the parting line.

  Referring to FIG. 2, the elastic deformability of the intermediate member (7) allows the bar (5) to be bent so that the bar (5) is positioned on the extension line of the intermediate member (7). Recognize. Referring to FIG. 7, after the fixator (2) is placed on the tissue wall (50), this same elastic deformability allows both bars (5, 6) to be placed in substantially the same plane. You can see that

  The bar (5) has a larger diameter than the diameter of the intermediate member (7). Thereby, the longitudinal direction rigidity of the bar (5) is larger than the longitudinal direction rigidity of the intermediate member (7). The bar (5) is connected to the intermediate member (7) in the central region of the bar (5). At the tip (tip with respect to the direction of needle engagement in the wall (50)), the bar (5) is provided with a lateral flange (10). The predetermined diameter of the lateral flange (10) will be described later. At the proximal end, the bar (5) is provided with an inclined surface (11). As shown in FIG. 2, the inclined surface (11) has the bar (5) directed toward the intermediate member (7) even though the intermediate member (7) has a central bulge (12). A clearance is formed so that it can be folded.

  The bar (6) also has a larger diameter than the diameter of the intermediate member (7). Thereby, the longitudinal direction rigidity of the bar (6) is larger than the longitudinal direction rigidity of the intermediate member (7). The bar (5) is also connected to the intermediate member (7) in the central region of the bar (6). The shape of the bar (6) is a pure cylindrical shape.

  The intermediate member (7) has a predetermined length as described later, in addition to the elastic deformability, the orientation state (direction), and the bulging portion (12) described above.

  The needle (3) is made of stainless steel. The needle (3) includes a linear base end portion (15) having a tube-like structure and an arcuate tip end portion (16). The diameter of the needle (3) gradually decreases towards the tip (17) of the needle. This reduction in diameter starts from the tip of the base end (15).

  Thus, the proximal end (15) forms a cavity (20). This cavity (20) has a constant diameter over a wide proximal region. The cavity diameter gradually decreases in the tip region. As shown in FIG. 2, the proximal portion of the cavity (20) receives the bar (5) and the intermediate member (7) by folding the bar (5) onto the extension of the intermediate member (7). be able to. The diameter of the flange (10) is slightly smaller than the diameter of the proximal end portion of the cavity (20). Therefore, the flange (10) is introduced and slid into the proximal region of the cavity (20) until the flange (10) is wedged in the distal region of the cavity (20). Can do.

  As further shown in FIG. 2, the length of the intermediate member (7) is such that when the flange (10) is positioned in such a way that it can form a sufficient wedge in the cavity (20), the bar (6) Is of such a length that it contacts the proximal end (21) of the needle (3). Such a sufficient wedge stop of the flange (10) forms a removable connection of the fixator (2) to the proximal end (15) of the needle (3). This connection is achieved by holding the kit (1), introducing the kit (1) into the patient's body, and inserting the needle (3) into the mounting target wall (50) during the operation of the fixing device (2). Is sufficiently strong so that it can continue to be securely fixed to the needle (3), and the operator attaches the needle (3) to the needle (3) after the fixing device (2) is locked to the wall (50). On the other hand, when a traction force is applied, it can be detached.

  In addition, the needle (3) is provided with a boss (25) protruding toward the inside of the cavity (20) at the proximal end portion. This boss (25) is formed in the wall of the needle (3) by partial stamping. This boss (25) can constitute a "hard point" that the flange (10) must exceed when separating the fixator (2) from the needle (3).

  Actually, as shown in FIGS. 4 to 7, a wall reinforcement (51) is arranged along the wall (50) to be reinforced, and then the kit (1) is attached to the wall (50). Move closer.

  In that case, the arched tip (16) of the needle (3) partially penetrates the reinforcement (51) and the wall (50), as in the conventional use for curved suture needles. It is inserted by a circular motion substantially centered on the center of the part (16) (FIG. 4).

  Thereafter, the distal end portion of the arch-shaped distal end portion (16) protruding from the wall (50) and the reinforcing body (51) after insertion is pulled while grasping, and the proximal end portion (15) of the needle is pulled to the wall (50). ) (FIG. 5). Thereby, a bar (6) is latched with respect to a reinforcement body (51). As a result, the wedge of the flange (10) is released, and the intermediate member (7) can be released from the cavity (20) as the proximal end (15) slides in the wall (50).

  Thereafter, the needle (3) is gradually pulled out from the wall (50) and the reinforcing body (51) by pulling the needle (3) in parallel with the direction in which the proximal end (15) is formed in FIG. Finally, it is completely pulled out (FIG. 6). At this point, the flange (10) is caught against the boss (25).

  Then, the flange (10) is moved beyond the boss (25) by pulling the needle (3) in parallel with the direction in which the proximal end (15) is formed in FIG. This pull allows the bar (5) to exit the cavity (20) at a position spaced from the reinforcement (51). Therefore, this bar (5) is drawn onto the reinforcing body (51) based on the elastic restoring force of the intermediate member (7). Thereby, a reinforcement body (51) is pressed with respect to a wall (50) (FIG. 7). Thereafter, the needle (3) is removed and discarded.

  The operation described above is repeated as many times as necessary at various locations with respect to the reinforcement (51) so that the reinforcement (51) can be completely fixed to the wall (50). Each time the fixing device (2) is arranged, a new kit (1) is used.

  Figures 8 to 11 show a kit (1) which is very similar to the kit described above. The difference from the previous kit is that the needle (3) is linear and penetrates the reinforcement (51) and the wall (50). In this case, the bar (5) is anchored inside the wall (50) after being separated from the needle (3).

  Figures 12 to 14 show an alternative embodiment of the fixator (2) and show a second embodiment of the kit (1). The same reference numerals are given to the members which have already been described with reference to the previous drawings.

  FIG. 12 shows a kit (1) in which the needle (3) is a conventional suturing needle. That is, the kit (1) is shown in which the needle (3) has a proximal end that can be crimped to the suture.

  In this case, the kit (1) includes a flexible thread-like portion (22). One end of the thread-like part (22) is connected to the proximal end of the needle (3) by crimping, and the other end of the thread-like part (22) is connected to the sleeve (23). The sleeve (23) receives the locking bar (5) and the intermediate member (7) of the fixing device (2).

  The thread-like portion (22) and the sleeve (23) are formed of a tube made of a heat-shrinkable material such as polytetrafluoroethylene (PTFE). This heat shrinkage of the material is carried out in the part of the tube intended to constitute the thread-like part (22). The detachable connection between the sleeve (23) and the fixator (2) is obtained by appropriate selection of the diameter of the heat shrinkable material tube. This diameter is selected such that friction occurs between the fixator (2) and the sleeve (23) when the fixator (2) is inserted into the sleeve (23).

  As shown in FIGS. 13 to 15, the thread-like portion (22) increases the possibility of movement of the needle (3) with respect to the fixator (2), and makes the operation of the needle easier. This thread-like part (22) also makes it possible to position the fixator (2) at a distance from the needle (3) when the needle (3) is operated. This eliminates the risk of premature separation of the fixator (2) and the needle (3) during operation.

  In the case of the kit (1) shown in FIG. 16, a side opening (24) is formed in the sleeve (23). The end of the locking bar (5) is detachably engaged in the side opening (or slot) (24). In this case, separation of the fixator (2) and the sleeve (23) can be obtained by tearing the sleeve wall partially or completely starting from the slot (24).

  The kit (1) shown in FIG. 17 also comprises a thread-like portion (22) and a sleeve (23), such as formed from a tube made of heat-shrinkable material. In this case, a tearable thread (25) that forms a loop around the bar (5) is placed in the tube before thermal contraction. This thread (25) allows a detachable connection between the sleeve (23) and the fixture (2).

  In the case of FIG. 18, the intermediate member (7) is long enough to allow multiple penetrations of the needle (3) through the wall (50).

  In the case of FIG. 19, it is formed as a thread that can be used to form a suture.

  This thread is wound around the bobbin when the kit (1) is introduced into the patient's body.

  In the case of FIG. 20, the needle (3) and the fixing device (2) are molded from the same material as an integral member. In this case, the needle (3) and the bar (5) are connected to each other via a material bridge (30). The material bridge (30) is dimensioned such that it can be broken by a force that exceeds the aforementioned threshold.

  As is apparent from the above, the present invention provides a kit (1) with a number of advantages compared to similar systems according to the prior art. The decisive advantage of the kit (1) according to the present invention is that it is simple and functional in structure and can result in a variety of uses. In particular, the kit according to the invention can be used very easily for both laparoscopic and direct access techniques. Anchoring can be obtained by accessing the wall in the wall area of the wall intended to receive the prosthesis member or by percutaneous access. The kit (1) can be configured to be disposable after a single use, and the tip of the needle can be any suitable shape, such as in particular a curved or arched shape, Various types of fixators can be used.

  The invention is not limited to the embodiments described above by way of example, and the invention encompasses all alternative embodiments that fall within the scope of protection defined by the claims. It goes without saying. Thus, the fixator (2) can be used not only to fix a prosthetic member, such as a wall reinforcement (51), particularly to the abdominal wall (50), but also between two anatomical walls or Two anatomical members can be used to connect each other, and can also be used to fix any other type of member to such a wall. A linear needle can be used to fix the member through the layer formed in the tissue. The means for detachably connecting the fixator (2) can comprise a slit formed in the proximal end of the needle. This provides flexibility with respect to the needle so that the retainer can be held. The curved needle can be of the “3/8” type, ie it can be of a type having a shape substantially corresponding to 3/8 of a circle. The fixator can extend beyond the proximal end of the needle.

It is a side view which shows the needle and fixing device in the state before an assembly regarding the kit by 1st Embodiment of this invention. It is the same figure as FIG. 1, Comprising: The mode after an assembly is shown. It is a figure which shows the fixing device seen from the arrow III direction in FIG. It is a side view which shows such a kit and the structure | tissue wall which makes the installation object of a fixing device, Comprising: Each step regarding installation of the fixing device in the wall is shown. It is a side view which shows such a kit and the structure | tissue wall which makes the installation object of a fixing device, Comprising: Each step regarding installation of the fixing device in the wall is shown. It is a side view which shows such a kit and the structure | tissue wall which makes the installation object of a fixing device, Comprising: Each step regarding installation of the fixing device in the wall is shown. It is a side view which shows such a kit and the structure | tissue wall which makes the installation object of a fixing device, Comprising: Each step regarding installation of the fixing device in the wall is shown. It is a side view which shows the kit which can be replaced | exchanged, and the structure | tissue wall which makes the installation object of a fixing device, Comprising: Each step regarding installation of the fixing device in the wall is shown. It is a side view which shows the kit which can be substituted, and the tissue wall which makes the installation object of a fixing device, Comprising: Each step regarding installation of the fixing device in the wall is shown. It is a side view which shows the kit which can be substituted, and the tissue wall which makes the installation object of a fixing device, Comprising: Each step regarding installation of the fixing device in the wall is shown. It is a side view which shows the kit by which it can substitute, and the tissue wall which makes the installation object of a fixing device, Comprising: Each step regarding installation of the fixing device in the wall is shown. FIG. 3 is a view similar to FIG. 2 and showing a fixator in a kit according to another embodiment of the present invention. It is a side view which shows the kit by other embodiment of this invention, and the tissue wall which makes the installation object of a fixing device, Comprising: Each step regarding installation of the fixing device in the wall is shown. It is a side view which shows the kit by other embodiment of this invention, and the tissue wall which makes the installation object of a fixing device, Comprising: Each step regarding installation of the fixing device in the wall is shown. It is a side view which shows the kit by other embodiment of this invention, and the tissue wall which makes the installation object of a fixing device, Comprising: Each step regarding installation of the fixing device in the wall is shown. FIG. 13 is a view similar to FIG. 12 showing a kit according to an alternative embodiment. It is a figure similar to FIG. 12, Comprising: It is a figure which shows the kit by other embodiment. FIG. 3 is a view similar to FIG. 2 showing a fixator in a kit according to an alternative embodiment. FIG. 3 is a view similar to FIG. 2 showing a fixator in a kit according to another alternative embodiment. It is a figure similar to FIG. 2, Comprising: It is a figure which shows the fixing device in the kit by other embodiment.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Kit 2 Fixing device 3 Needle 5 1st locking bar (front end side bar, locking member)
6 Second locking bar (base end side bar, locking member)
7 Intermediate member (thread-like member)
10 Flange (Means for detachably connecting)
15 Base end portion 20 Cavity 21 Base end 22 Threaded portion 23 Sleeve 24 Side opening 30 Material bridge (means for detachably connecting)
50 walls

Claims (9)

A kit (1) comprising a medical fixator (2) and a needle (3) for arranging the fixator (2),
The needle (3) can penetrate one or a plurality of walls (50) to which the fixing device (2) is attached, or can penetrate a part of the thickness of such a wall. ,
At least one locking member (5) in which the fixing device (2) can be engaged with the wall (50), and a deformable thread-like member (7) connected to the locking member (5). ) And
The fixing device (2) can be elastically deformed in a connection region between the locking member (5) and the deformable thread-like member (7), whereby the locking member (5) An elastic deformation position where the locking member (5) and the deformable thread-like member (7) can be substantially inscribed in the cross-section of the needle (3) with respect to the thread-like member, and the locking member And a non-deformable position such that (5) engages the one or more walls (50) and ensures anchoring of the fixator (2). ,
In such a kit (1),
Means (3, 10) for releasably connecting the locking member (5) to the base end (15) of the needle (3) by the needle (3) and the fixing device (2). 30)
This connection is achieved when the kit (1) is introduced into the patient's body while holding the kit (1) and the needle (3) is inserted into the wall (50) during the operation. The member (5) is sufficiently strong so that the member (5) can be securely fixed to the needle (3), and a traction force is applied to the needle (3) in the insertion direction of the needle (3). When the stress on the fixing device (2) exceeds a predetermined threshold value, it can be detached.
By this detachment of the fixing device, the locking member (5) can be brought into the non-deformed position based on the elastic restoration of the connection ,
The needle (3) comprises an internal cavity (20) open at the proximal end (15);
The needle (3) receives in the cavity (20) the locking member (5) of the fixator;
The detachable connecting means is
A wall portion of the needle (3) defining the cavity (20) and the locking member (5) of the fixing device (2), wherein in this case, the cavity (20) The dimension and the dimension of the locking member (5) are such that there is friction between the locking member (5) and the wall portion of the needle (3), and / or
One that projects towards the inside of the cavity (20) and that can form a “difficulty” that the locking member (5) must overcome when separating the fixator (2) Alternatively, a kit comprising a plurality of bosses (25) . The kit (1) according to claim 1 ,
Each of the bosses (25) is formed by partial stamping in the proximal end portion of the needle (3). The kit (1) according to claim 1 or 2 ,
The needle (3) has a constant diameter over the proximal region intended to receive the fixator (2) and gradually decreases in diameter in the distal region A proximal cavity (20),
The fixing device (2) includes a distal end side bar (5), a proximal end side bar (6), and an intermediate member (7) connecting the bars (5, 6) to each other; The bar (5) has a flange (10) whose diameter is slightly smaller than the diameter in the proximal region of the cavity, so that the flange (10) is connected to the cavity (20). The flange (10) can be introduced and slid into the proximal region of the cavity (20) until it is wedged in the distal region of When the length of the intermediate member (7) is positioned such that the flange (10) can form a sufficient wedge in the cavity (20), the proximal bar (6) Is the needle (3) Such as to be in contact with the proximal end (21), the kit characterized in that it is the length. A kit (1) comprising a medical fixator (2) and a needle (3) for arranging the fixator (2),
The needle (3) can penetrate one or a plurality of walls (50) to which the fixing device (2) is attached, or can penetrate a part of the thickness of such a wall. ,
At least one locking member (5) in which the fixing device (2) can be engaged with the wall (50), and a deformable thread-like member (7) connected to the locking member (5). ) And
The fixing device (2) can be elastically deformed in a connection region between the locking member (5) and the deformable thread-like member (7), whereby the locking member (5) An elastic deformation position where the locking member (5) and the deformable thread-like member (7) can be substantially inscribed in the cross-section of the needle (3) with respect to the thread-like member, and the locking member And a non-deformable position such that (5) engages the one or more walls (50) and ensures anchoring of the fixator (2). ,
In such a kit (1),
Means (3, 10) for releasably connecting the locking member (5) to the base end (15) of the needle (3) by the needle (3) and the fixing device (2). 30)
This connection is achieved when the kit (1) is introduced into the patient's body while holding the kit (1) and the needle (3) is inserted into the wall (50) during the operation. The member (5) is sufficiently strong so that the member (5) can be securely fixed to the needle (3), and a traction force is applied to the needle (3) in the insertion direction of the needle (3). When the stress on the fixing device (2) exceeds a predetermined threshold value, it can be detached.
By this detachment of the fixing device, the locking member (5) can be brought into the non-deformed position based on the elastic restoration of the connection,
A flexible thread-like part (22),
The thread-like portion (22) is connected to the proximal end of the needle (3) and a sleeve (23) that receives the locking member (5) of the fixator (2) ;
The detachable connecting means is
The sleeve (23) of the sleeve (23) such that friction may be present between the fixer (2) and the sleeve (23) when the fixator (2) is inserted into the sleeve (23); And / or dimensions of said fixture (2); and / or
A side opening (24) formed in the sleeve (23), in which a part of the fixing device (2), such as in particular one end of the locking member (5), is detachably engaged; Having a lateral opening (24); and / or
A thread (25) present in the sleeve (23), which is detachably engaged with the periphery of the locking member (5, 7) of the fixing device (2); have;
Kit characterized by that. The kit (1) according to claim 4 ,
The kit characterized in that the thread (25) forms a loop around the locking member (5, 7) of the fixing device (2) and can be cleaved. A kit (1) comprising a medical fixator (2) and a needle (3) for arranging the fixator (2),
The needle (3) can penetrate one or a plurality of walls (50) to which the fixing device (2) is attached, or can penetrate a part of the thickness of such a wall. ,
At least one locking member (5) in which the fixing device (2) can be engaged with the wall (50), and a deformable thread-like member (7) connected to the locking member (5). ) And
The fixing device (2) can be elastically deformed in a connection region between the locking member (5) and the deformable thread-like member (7), whereby the locking member (5) for the thread-like members, and the elastic deformation position as said locking member (5) and the deformable thread members (7) and can be substantially inscribed within the cross section of the needle (3), said locking member And a non-deformable position such that (5) engages the one or more walls (50) and ensures anchoring of the fixator (2). ,
In such a kit (1),
Means (3, 10) for releasably connecting the locking member (5) to the base end (15) of the needle (3) by the needle (3) and the fixing device (2). 30)
This connection is achieved when the kit (1) is introduced into the patient's body while holding the kit (1) and the needle (3) is inserted into the wall (50) during the operation. The member (5) is sufficiently strong so that the member (5) can be securely fixed to the needle (3), and a traction force is applied to the needle (3) in the insertion direction of the needle (3). When the stress on the fixing device (2) exceeds a predetermined threshold value, it can be detached.
By this detachment of the fixing device, the locking member (5) can be brought into the non-deformed position based on the elastic restoration of the connection,
The needle (3) and the locking member (5) of the fixing device (2) are connected to each other via a material bridge (30),
This material bridge (30) constitutes said detachable connecting means,
A kit characterized in that the material bridge (30) is dimensioned such that it can be broken by a force exceeding the predetermined threshold. The kit (1) according to claim 6 ,
The kit, wherein the needle (3) and the fixing device (2) are molded from the same material as an integral member. A method for producing a kit according to claim 4 or 5 , comprising:
-Preparing a tube made of a heat-shrinkable material such as polytetrafluoroethylene (PTFE),
The thermal contraction of this material is carried out in the part of the tube intended to constitute the flexible thread-like part (22) and in the remainder intended to form the sleeve (23) Does not heat shrink,
A method characterized by that. In 請 Motomeko 8 method described,
Prior to the thermal contraction, the thread (25) is engaged in the tube.

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